Brief Title
Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients
Official Title
Appropriateness Evaluation of Follow up Procedures in Gynaecology Oncology TOTEM Study: Multicentric Randomized Controlled Clinical Trial Between Two Follow up Regimens With Different Tests Intensity in Endometrial Cancer Treated Patients.
Brief Summary
This study aims to compare two different follow up regimens with different test intensity in endometrial cancer treated patients. If eligibility criteria are satisfied and the written informed consensus is obtained, patients are stratified inside the centre according to their risk level: - Group 1 : patients at low risk of recurrence [stage IA G1 and stage IA G2] - Group 2 : patients at high-risk of recurrence [≥ stage IA G3] (Ethics Committee amendment of 14th September 2010, use new 2010 FIGO classification for endometrial cancer!) In each group patients will be randomized in two regimens of follow up: 1. Minimalist (Arm 1) 2. Intensive (Arm 2) Features of each arm are listed in "Arms" item.
Detailed Description
The procedure for centralized randomization, with blocks of variable length, will take place within each layer with 1:1 ratio and will be implemented within the centralized database, with sequences generated by dedicated software. The recruitment and randomization has to be registered on the website (www.epiclin.cpo.it) no later than 20 days after histological examination has been received. If patients do not need any kind of adjuvant therapy they will start follow-up program according to the regimen chosen for them at randomization, if adjuvant therapy is needed the patient at first will be registered and the randomization will be deferred at the end of treatment. In presence of symptoms or signs detected during the clinical visit which may suppose a recurrence or in presence of abnormal tests, the clinician has to prescribe all medical tests and examinations required. The tests carried out in addition to follow-up scheduled program must be reported in the database. Nevertheless patients continue to be followed for the assessment of the performance status at 5 years, but the follow-up schedule is up to the clinician. An interim analysis is scheduled in 3.5 years starting from the beginning of recruitment (based on approximately 1 / 3 of the total expected events, when about 4 / 5 cases have already been enrolled). Patients will be stratified by recruitment Center, by level of risk (calculated according to the stage of the disease, the histotype and the grading) and by type of treatment performed. The focus of the study is to: - Compare the effect of two FU regimens on 5-years OS - Evaluate the difference in diagnosis anticipation - Evaluate the difference in terms of recurrences - Describe the compliance and QoL of patients - Evaluate the cost-effectiveness and the cost-utility
Study Type
Interventional
Primary Outcome
Overall survival
Secondary Outcome
Progression-free survival
Condition
Endometrial Cancer
Intervention
Intensive/Low-Risk follow up (IA G1; IA G2)
Study Arms / Comparison Groups
Intensive follow up
Description: Intensive follow up in low-risk patients Intensive follow up in high-risk patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1884
Start Date
September 2008
Completion Date
December 2020
Primary Completion Date
July 31, 2018
Eligibility Criteria
Inclusion Criteria: - patients treated surgically for endometrial cancer, if in complete clinical remission confirmed by imaging stage FIGO I-IV - no previous or concurrent neoplasia (with the exception of carcinoma in situ of the cervix and basalioma of the skin) - other contemporaneous RCT may be allowed if there is not any restriction concerning follow up - obtaining a written informed consensus before randomization - age > 18 years Exclusion Criteria: - presence of any psychological, familial, sociological or geographical condition that could potentially limit the compliance to the protocol and the follow-up planned: all these situations must be discussed with the patient before the randomization - previous, concurrent or second malignancies endometrial carcinoma in the context of a hereditary syndrome - conditions which contraindicate medical tests scheduled according to follow-up regimen
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paolo Zola, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00916708
Organization ID
TOTEM
Responsible Party
Principal Investigator
Study Sponsor
Azienda Ospedaliera San Giovanni Battista
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Study Sponsor
Paolo Zola, MD, Principal Investigator, Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin
Verification Date
August 2018